HA-1A (Centoxin - Centocor), a monoclonal IgM antibody against endotoxin from gram-negative bacteria, may soon be approved for marketing by the US Food and Drug Administration. Commercially available in Europe, HA-1A has been used in the USA as an investigational drug. E5 (Xomen - Xoma), another monoclonal IgM antibody against endotoxin, is also available here for investigational use.

Quinupristin and dalfopristin, two streptogramin antibacterials marketed in a 30:70 combination as Synercid, have received accelerated approval from the FDA for intravenous treatment of bacteremia and life-threatening infection....

A new albumin-bound formulation of paclitaxel (Abraxane - American Pharmaceutical Partners) has been approved by the FDA for treatment of metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. This formulation is free of polyoxyethylated castor oil (Cremophor), a solvent thought to contribute to the hypersensitivity reactions that occur frequently with standard paclitaxel (Taxol, and others) and are severe in about 3% of patients.

Eteplirsen (Exondys 51 – Sarepta), an antisense oligonucleotide, has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the dystrophin gene that is amenable to exon 51 skipping. It is the first drug to be approved for treatment of DMD.

The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Retifanlimab-dlwr (Zynyz – Incyte), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with carboplatin and paclitaxel for first-line treatment of unresectable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as monotherapy in patients who had disease progression or intolerance to platinum-based chemotherapy. The drug received accelerated approval for treatment of recurrent locally advanced or metastatic Merkel cell carcinoma in 2023.

Alemtuzumab (Campath), a genetically engineered, humanized monoclonal antibody currently approved to treat B-cell chronic lymphocytic leukemia (BCLL) and used off-label for induction therapy in solid organ transplants, is now also being tried off-label for treatment of relapsing multiple sclerosis (MS).

The drugs of choice for treatment of fungal infections are listed in the table that begins on page 62. Some of the indications and dosages recommended here have not been approved by the FDA. More detailed guidelines for some of these infections are available online from the Infectious Diseases Society of America (www.idsociety.org).

Drugs for gout are used to reduce the pain and inflammation of acute flares, decrease the frequency of exacerbations, and lower serum urate levels to prevent recurrent flares, development of tophi, and joint damage.

Gemtuzumab ozogamicin, a monoclonal antibody bound to a cytotoxic antibiotic, has been approved by the FDA for treatment of patients with CD33-positive acute myeloid leukemia (AML) in first relapse who are more than 60 years old and may not be able to tolerate cytotoxic chemotherapy